A fixed-dose combination analgesic and antispasmodic medication used for the management of moderate to severe pain associated with smooth muscle spasm, particularly in abdominal and renal colic. Dicyclomine provides anticholinergic and antispasmodic action, Paracetamol acts as a central analgesic and antipyretic, and Tramadol is a centrally-acting opioid analgesic with dual mechanism (mu-opioid receptor agonist and serotonin/norepinephrine reuptake inhibition). This combination is particularly relevant in the Indian context for treating pain from conditions like renal calculi, biliary colic, and dysmenorrhea.
Adult: 1 tablet every 4-6 hours as needed for pain. Maximum: 4 tablets in 24 hours. Should be used at the lowest effective dose for the shortest duration.
Note: Take with or after food to minimize gastric upset. Swallow whole with a glass of water. Do not crush, chew, or break. Do not consume alcohol. Can be taken for acute episodes; treatment duration should not exceed 5 days without medical supervision.
The combination provides multimodal analgesia and spasmolysis. Tramadol binds to μ-opioid receptors and weakly inhibits serotonin and norepinephrine reuptake in the CNS, altering pain perception. Paracetamol's exact mechanism is unclear but involves central COX inhibition, activation of descending serotonergic pathways, and possible CB1 receptor interaction. Dicyclomine is a direct smooth muscle relaxant (papaverine-like) and a competitive muscarinic acetylcholine receptor antagonist, reducing spasms in the GI and genitourinary tracts.
Pregnancy: Category C (US FDA). Tramadol: Avoid in third trimester (risk of neonatal withdrawal). Paracetamol: Generally considered safe. Dicyclomine: Category B. Use only if clearly needed and benefit outweighs risk. Not recommended for routine use.
Driving: May cause dizziness, drowsiness, blurred vision. Patients should NOT drive or operate heavy machinery until they know how the drug affects them.
| CNS Depressants (Alcohol, Benzodiazepines, Barbiturates) | Additive CNS depression, respiratory depression, sedation | Major |
| MAO Inhibitors (Phenelzine, Selegiline) | Risk of serotonin syndrome, hyperpyrexia, seizures | Contraindicated |
| SSRIs/SNRIs (Fluoxetine, Sertraline, Venlafaxine) | Increased risk of serotonin syndrome | Major |
| Other Anticholinergics (Atropine, Antihistamines, TCAs) | Additive anticholinergic effects (dry mouth, urinary retention, constipation) | Major |
| CYP2D6 Inhibitors (Quinidine, Fluoxetine, Paroxetine) | Reduced conversion of Tramadol to active M1 metabolite, may decrease analgesia | Moderate |
| CYP3A4 Inducers (Rifampicin, Carbamazepine, Phenytoin) | Increased Tramadol metabolism, reduced efficacy | Moderate |
| Warfarin | Paracetamol may potentiate anticoagulant effect with chronic high doses | Moderate |
| Metoclopramide, Domperidone | Antagonized by Dicyclomine's anticholinergic effect | Moderate |
Same composition (Dicyclomine (10mg) + Paracetamol (325mg) + Tramadol (50mg)), different brands: